BEUDAMED
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    Monarch Platform

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MONARCH PLATFORM

    FDA Adverse Event
    Injury ·AURIS HEALTH, INC.·Product code EOQ·September 6, 2022

    NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACRYSOF RESTOR

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD.·Product code MFK·October 23, 2008

    REPLY SR

    FDA Adverse Event
    Malfunction ·SORIN BIOMEDICA CRM S.R.L.·Product code DXY·August 15, 2011

    GYNECARE TVT-AA ABDOMINAL

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 8, 2013

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025